A05449 Summary:

BILL NO A05449
SAME AS No same as
SPONSOR Englebright (MS)
COSPNSR Lupardo
MLTSPNSR
Amd S2803-e, Pub Health L
Provides that residential health care facilities may return and redistribute
unused medication provided that such medication is in the manufacturer's
original, tamper evident packaging; directs the commissioner of health to
establish a reasonable fee of reimbursement of costs related to the receipt,
restocking and redistribution of such medication payable to the pharmacy to
which such medication is returned.

A05449 Actions:

A05449 Votes:

A05449 Memo:

BILL NUMBER:A5449
TITLE OF BILL: An act to amend the public health law, in relation to
return and redistribution of unused medication
PURPOSE OR GENERAL IDEA OF BILL:
To clarify provisions governing the return and redistribution of
unused medication provided in certain residential health care
facilities, provide for a reasonable fee for the costs of such return
and redistribution and to direct the establishment of an electronic
method by which a pharmacy can effectuate such returns for Medicaid
purposes.
SUMMARY OF PROVISIONS:
Section 1. Amends Section 2803-e (1) of the public health law to
further clarify how unused medications must be packaged to be
received, restocked and redistributed by a pharmacy; amends
subdivision 2 of such section to direct the commissioner of health, in
consultation with an advisory committee, to establish a reasonable fee
of reimbursement of costs related to the receipt, restocking and
redistribution of such medications to the pharmacy; adds a new
subdivision 5 to such section to direct the commissioner to establish
procedures to assure that any such return of medications, receipt,
restocking or redistribution, comply with HIPAA and related electronic
submission requirements; adds a new subdivision 6 to such section to
establish the advisory committee referred to in subdivision 2.
Subdivision 7 restricts civil liability of prescription drug
manufacturers under certain circumstances.
JUSTIFICATION:
In a recent Medicaid update, the Department of Health (DOH) provided
guidelines for unused medication in a nursing home setting suggesting
that nursing home pharmacy services providers reimburse or credit the
nursing home or purchaser of such drug product for the unused
medication that is restocked and redispensed, noting that drugs listed
on the Medicaid Nursing Home Carve-Out List must be credited back to
the Medicaid program. Unfortunately, electronic coding standards
required by HIPAA currently contain no codes for issuing a credit to a
payor, thus making implementation of such a return credit policy
unworkable. This legislation directs DOH to establish procedures to
assure an efficient process, including access to the original claim,
reversal, adjustment and rebilling activities reflecting the credit.
The bill further directs the commissioner of health to establish a fee
to cover the costs of processing such returns and credits. "Return" is
not simply "dispensing in reverse", requiring several safeguards,
manual processes and tracking activities which are costly. An advisory
committee is established in the bill to assist the commissioner in
determining such fee.
PRIOR LEGISLATIVE HISTORY:
2007-08: S.652 Referred to Health
2009-10: S.3500 Referred to Health
2011-12 A.4150A referred to Health
2013-14 A.4643 referred to Health
FISCAL IMPLICATIONS:
None to the state.
EFFECTIVE DATE:
This act shall take effect on the 120th day after enactment.

A05449 Text:

S T A T E O F N E W Y O R K
________________________________________________________________________
5449
2015-2016 Regular Sessions
I N A S S E M B L Y
February 23, 2015
___________
Introduced by M. of A. ENGLEBRIGHT, LUPARDO -- read once and referred to
the Committee on Health
AN ACT to amend the public health law, in relation to return and redis-
tribution of unused medication
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
1 Section 1. Section 2803-e of the public health law, as added by chap-
2 ter 902 of the laws of 1977 and renumbered by chapter 340 of the laws of
3 1980, is amended to read as follows:
4 S 2803-e. Residential health care facilities; return and redistrib-
5 ution of unused medication. 1. Notwithstanding any inconsistent
6 provision of law, rule or regulation to the contrary, the commissioner
7 is hereby authorized and directed to permit either a resident or
8 consultant pharmacist OR HIS OR HER DESIGNEE in a residential health
9 care facility to return to the pharmacy from which it was purchased any
10 unused medication provided that such medication is sealed in THE
11 MANUFACTURER'S ORIGINAL unopened[,] TAMPER EVIDENT PACKAGING AND EITHER
12 individually packaged [units] OR PACKAGED IN UNIT-DOSE PACKAGING and
13 within the recommended period of shelf life, AND, IF ORAL OR PARENTERAL
14 MEDICATIONS, SEALED IN SINGLE-DOSE CONTAINERS APPROVED BY THE FEDERAL
15 FOOD AND DRUG ADMINISTRATION, AND, IF A TOPICAL OR INHALANT DRUG, IS
16 SEALED IN UNITS-OF-USE CONTAINERS APPROVED BY THE FEDERAL FOOD AND DRUG
17 ADMINISTRATION and provided that such medication is not a controlled
18 substance as defined in section thirty-three hundred six of [the public
19 health law] THIS CHAPTER.
20 2. The pharmacy to which such medication as described in subdivision
21 one of this section is returned shall be permitted to receive, restock
22 and redistribute that medication. THE COMMISSIONER, IN CONSULTATION
23 WITH THE ADVISORY COMMITTEE ESTABLISHED BY SUBDIVISION SIX OF THIS
24 SECTION, SHALL ESTABLISH A REASONABLE FEE OF REIMBURSEMENT OF COSTS
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD08994-01-5
A. 5449 2
1 RELATED TO THE RECEIPT, RESTOCKING AND REDISTRIBUTION OF SUCH MEDICATION
2 PAYABLE TO THE PHARMACY TO WHICH SUCH MEDICATION IS RETURNED.
3 3. The pharmacy to which such medication as described in subdivision
4 one of this section is returned shall be required to reimburse or credit
5 the purchaser of that medication for the unused medication that is
6 restocked and redistributed. No pharmacy shall be required to accept any
7 medication returned under subdivision one of this section.
8 4. Neither an individual patient or the state, if a patient is a
9 recipient of a state funded program, shall be charged for unused medica-
10 tion which according to the provisions of this law is returned for
11 reimbursement or credit.
12 5. THE COMMISSIONER SHALL ESTABLISH PROCEDURES TO ASSURE THAT ANY
13 RETURN OF MEDICATIONS AUTHORIZED BY THIS SECTION, AND ANY RECEIPT,
14 RESTOCKING OR REDISTRIBUTION OF MEDICATION SO RETURNED SHALL COMPLY WITH
15 THE FEDERAL HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)
16 OF 1996, AS AMENDED.
17 6. THE DEPARTMENT SHALL CONVENE AN ADVISORY COMMITTEE TO ASSIST THE
18 COMMISSIONER IN DEVELOPING A REASONABLE FEE OF REIMBURSEMENT PURSUANT TO
19 THE PROVISIONS OF SUBDIVISION TWO OF THIS SECTION. THE ADVISORY COMMIT-
20 TEE SHALL BE COMPRISED OF LICENSED PHARMACISTS CURRENTLY ENGAGED IN THE
21 PROVISION OF LONG TERM CARE PHARMACY SERVICES. MEMBERS OF THE COMMITTEE
22 SHALL BE APPOINTED BY THE GOVERNOR: TWO MEMBERS OF THE COMMITTEE SHALL
23 BE APPOINTED ON THE RECOMMENDATION OF THE TEMPORARY PRESIDENT OF THE
24 SENATE AND THE SPEAKER OF THE ASSEMBLY; AND TWO MEMBERS SHALL BE
25 APPOINTED ON THE RECOMMENDATION OF THE MINORITY LEADER OF THE ASSEMBLY
26 AND THE MINORITY LEADER OF THE SENATE.
27 7. A PRESCRIPTION DRUG MANUFACTURER SHALL NOT, IN THE ABSENCE OF BAD
28 FAITH, BE SUBJECT TO CRIMINAL OR CIVIL LIABILITY FOR INJURY, DEATH, OR
29 LOSS TO PERSON OR PROPERTY FOR MATTERS RELATED TO THE RETURN, DONATION,
30 ACCEPTANCE, REDISTRIBUTION OR DISPENSING OF A PRESCRIPTION DRUG MANUFAC-
31 TURED BY THE PRESCRIPTION DRUG MANUFACTURER THAT IS DONATED BY ANY
32 PERSON UNDER THE PROGRAM, INCLUDING BUT NOT LIMITED TO LIABILITY FOR
33 FAILURE TO TRANSFER OR COMMUNICATE PRODUCT OR CONSUMER INFORMATION OR
34 THE EXPIRATION DATE OF THE DONATED PRESCRIPTION DRUG.
35 S 2. This act shall take effect on the one hundred twentieth day after
36 it shall have become a law; provided, however, that the commissioner of
37 health shall promulgate rules and regulations prior to such effective
38 date.